24 and 25 June 2019, Mannheim, Germany - This seminar delivers profound know-how of the labelling process chain from preparation of the package insert, the artwork and the packaging up to GMP-relevant aspects. Afterwards, you are up-to-date with regulatory requirements.
9 - 10 April 2019 in Frankfurt, Germany - Update your English writing skills - with many practical exercises: free writing versus regulatory restrictions; editing and proofreading documents; package leaflet - regulatory linguistic restrictions and user-friendly writing.
28 June 2018 in Cologne, Germany, and 4 December 2018 in Berlin, Germany - Product information: SmPC, package insert and labelling
Using German package leaflets over the period from 2005 to 2015 as example, the study results show significant improvements, such as the increase in font sizes, line spacing and the more frequent use of highlighting. However, a significant increase in the volume of text has been found.
Read more29 - 29 June in Berlin, Germany, 7 - 8 December 2017 in Cologne, Germany - Product information, including workshop to prepare SmPC, package insert and labelling
26 January 2017, Cologne, Germany - QRD template implementation, company-internal adjustments, practical exercises
The results in the written readability test with 234 participants do not show an advantage of the landscape format over the portrait format. This finding negates the EU readability guideline’s stated preference for the landscape format.
Our analysis over 3 years of all English-language package leaflets available on the EMA website showed a significant text increase in package leaflets, whereby one mean reason is the huge text increase of the QRD template.
Read moreResource-saving solutions that additionally guarantee a good standard of legibility for package leaflets, such as text compression and targeted paper selection, can be found in the following.
Dr. Anna Wolf finalised her extensive work in February 2015 concerning the QRD template of the European Union, under PAINT-Consult’s supervision at the University of Bonn.
Read moreThe results of two investigations of 258 randomly selected German package leaflets show that opacity is a more appropriate tool for assessing paper quality than the paper weight recommended in the readability guideline.
Since QRD template version 9.1 this list is no longer essential.
Read moreDissertation, 2015
26 - 27 February 2015, Bonn, Germany - Workshop: experience with readability user testing, using QRD templates
Discussion to date: September 2015
Expirience with readability user testing (RUT), using QRD templates
PharmInd, 2015, 77(9):1380-1383
Discussion to date: May 2015
Use of sample/reference texts and QRD templates, practical exercises for using the QRD template, readability user testing and bridging studies
Original German title: Handling des steten Textzuwachses in Packungsbeilagen
10 - 12 February 2014, Bonn , Germany - Workshop: use of QRD templates, questions relating to labeling
Use of QRD templates, questions relating to labeling
PharmInd, 2014, 76(8):1312-1322
Address: Wenigenjenaer Ufer 12, 07749 Jena, Germany
Original German title: QRD-Template: Harmonisierung von Produktinformationstexten
Use of QRD templates
17 - 18 January 2013, London, United Kingdom - Presentation: Learning from current experience - did readability tests improve the quality of information and satisfy patients' needs?
Learning from current experience - did readability tests improve the quality of information and satisfy patients‘ needs?
Original German title: Patientenfreundliche Packungsbeilagen unter ökonomischen und regulatorischen Gesichtspunkten
Discussion to date: July 2012
The new QRD templates for product information
PharmInd, 2012, 74(9):1540-1549
The Forsa Opinion Research Institute, acting on behalf of the ERGO Insurance Group AG, interviewed 2600 people. The results show that package inserts are the most comprehensible product information in Germany.
14 February 2012, Berlin, Germany - Presentation: The new QRD templates for product information
Discussion to date: April 2012
Using the new QRD templates
Original German title: Wie wird der Beipackzettel patientenfreundlicher?
PAINT-Consult developed a model template with only 200 words, which has significant advantages over the QRD template (PDF). In a second study, the development of the QRD template from 1996 to 2012 was analysed (PDF).
PharmInd, 2012, 74(1):126-136
6 April 2011, London, UK - Presentation: The "ideal" OTC package insert
Original German title: Packungsbeilagen immer mehr überfrachtet
Original German title: Welche Impfung ist sinnvoll?
The ideal OTC package insert
14 February 2011, Berlin, Germany - Presentation: Readability Guideline and Labelling: Current experience on implementation and readability tests.
Original German title: Arzneimittelfälschungen und Scheinsicherheit
Original German title: Klatsche für Arzneimittel-Plagiate
The coming QRD templates
CMDh once again recommended PAINT-Consult's written readability test method as an alternative
Read moreOriginal German title: Update des QRD-Templates und daraus resultierende Änderungen in Packungsbeilagen und Fachinformationen
Readability Guideline & Labelling: Recent experience on implementation and readability tests
Original German title: Die Packungsbeilage - noch immer "ein Buch mit sieben Siegeln"?
26 November - 3 December 2010, University of Bonn, Germany - Presentation: Patient information via package inserts within the European Union
Supervised by PAINT-Consult, Dr. Claudia Hertzsch completed her dissertation relating to: Possibilities and limitations in preparing patient-friendlier package inserts with regard to content, formal design and amount of text.
PharmInd, 2010, 72(4):602-606
Original German title: Die Packungsbeilage: Anforderungen des Haftungsrechts
Original German title: Unzureichender Impfstatus von Medizin- und Pharmaziestudenten
Original German title: Möglichkeiten und Grenzen einer patientenfreundlicheren Gestaltung von Packungsbeilagen im Hinblick auf Inhalte, formale Gestaltung und Textumfang
PharmInd, 2010, 72(12):2032-2036
Discussion to date: October 2010
Patient information via package inserts within the European Union
Original German title: Wenn des Guten zu viel ist - Die Packungsbeilagen von Medikamenten sollen verständlicher werden
International Journal of Clinical Pharmacology and Therapeutics, 2010, 48(12):781-790 Fuchs J et al.
Discussion to date: February 2010
User friendly patient information via package inserts - status and perspectives
Original German title: Enormer Textzuwachs in Packungsbeilagen
Drug Information Journal, 2010, 44(2):119-129
PAINT-Consult completes the PAINT3 study - a readability test study of 271 randomly selected German package inserts with 5091 participants.
Original German title: Impfprophylaxe: Beratung in der Apotheke
Original German title: Packungsbeilagen in die Beratung einbeziehen
Original German title: Brandenburg/Mecklenburg-Vorpommern: Impfberatung in Apotheken
Original German title: Patientengerechte Arzneimittelinformation in Packungsbeilagen
In the readability guideline (PDF) the European Commission stipulated a minimum font size of 9pt as recommended by PAINT-Consult, instead of the previously recommended 12 to 20pt (PDF). This is based on the font size study of PAINT-Consult published in May 2008 (PDF).
Pharmacy Practice, 2009, 7(3):170-174
5 December 2008, London, United Kingdom - Presentation: The way forward on user testing - CRO's perspective
Original German title: Die große Impfberatung in Thüringens Apotheken
Original German title: Wie genau lassen sich Tabletten teilen?
Original German title: Lesbarkeitstest Methoden, Bridging, Ausnahmen
Original German title: Beipackzettel - Für Laien leicht verständlich
The way forward on user testing - CRO's perspective
PharmInd, 2008, 70(5):584-592
PAINT2 study is accomplished. This is an analysis of 271 package inserts randomly chosen from those available on the German medicine market in 2005.
Original German title: Sind Packungsbeilagen optimierbar?
Scientific leadership of the large vaccination advice campaign for pharmacies in Mecklenburg-Western Pomerania (Germany) during 2007, including training courses for pharmacy staff
Original German title: Ordnung in die Zettelwirtschaft
PharmInd, 2007, 69(2):165-172
Is splitting tablets an appropriate method to save medical costs
Original German title: Klartext statt Fachjargon
German Medical Science GMS Publishing House, 2007
Original German title: Gegen Grippe, Pneumokokken etc.: Welche Impfungen brauche ich als Diabetiker?
German Medical Science GMS Publishing House, Oktober 2006
Original German title: Packungsbeilagen - Text muss kürzer werden
Original German title: Wie muß ein guter Beipackzettel aussehen?
Original English title: The provision of pharmaceutical advice improves patient vaccination status
Discussion to date: October 2006
Original German title: Patienteninformationen vom IQWIG
Original German title: Lesbarkeitstests für Beipackzettel - Zu Risiken und Nebenwirkungen
Discussion to date: September 2006
Scientific leadership of the large vaccination advice campaign for pharmacies in Brandenburg (Germany) during 2007, including training courses for pharmacy staff
Scientific leadership of the large vaccination advice campaign in pharmacies throughout Thuringia (Germany) during 2005, including training courses for pharmacy staff
Original German title: Impfberatung in der Apotheke
Workshop
Vaccination advice in pharmacies
Hospital Pharmacy Europe, 2005, 21(4):29-31
Dissertation, 2015
Vaccination advice in pharmacies: workable, efficient, essential
The PAINT1 study is accomplished. Using a cross-over study design and the written readability test, the PAINT1 study investigated five original and five model package inserts with 1105 participants.
Original German title: Viele Packungsbeilagen weisen Mängel auf
Original German title: Die Packungsbeilage von Arzneimitteln - Patientenwünsche und Realität
Original German title: Gestaltung von Packungsbeilagen für Arzneimittel
Last update: 15.08.2019
